Irving de Torre

About Irving de Torre

I’m a strategic, results-driven Director of Quality Assurance with deep expertise in FDA-regulated medical devices, biopharmaceuticals, and biotechnology. I specialize in building and harmonizing global Quality Management Systems (QMS), ensuring regulatory compliance, and driving operational excellence across complex, multi-site organizations.With a solid foundation in quality systems, global regulatory frameworks, and organizational development, I lead cross-functional teams to deliver measurable improvements in performance, efficiency, and compliance. I prioritize clear, collaborative communication to foster a proactive culture of quality that aligns with business objectives and supports long-term growth.Key Skills Leadership and Development: Strategic Team Leadership | Mentorship | Organizational Development Global Regulatory Expertise: FDA 21 CFR | ISO13485 | ISO14971 | MDSAP | EUMDR Compliance Quality Systems Optimization: Multi-Site QMS Harmonization | KPI Monitoring | Process Simplification Change Management: Enterprise-Level Transformations | CAPA | Risk-Based Quality Frameworks Audit Management: Internal/External Audits | FDA Inspections | Notified Body Readiness Technical Proficiency: Design Controls | Risk Management | eQMS Implementation | PDLM Processes

Experience

1. Site Head of Quality

   WACKER

   Jun 2025 — Present · San Diego, CA, US

Education

• Monterrey Institute of Technology (ITESM)

  Undergraduate, Industrial and Systems Engineering

• San Diego State University

  MS, Regulatory Affairs

• The University of Texas at El Paso

  Graduate, Master in Business Administration